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Microbiome and Sarcopenia in Patients With Liver Cirrhosis

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Re-verified, no change to tracked fieldsv12
  2. Primary completion date: Jul 2023 to Dec 2026 Completion date: Dec 2024 to Dec 2026v11 Show 1 more changeShow less
    • Completion date: Dec 2024 to Dec 2026
  3. Re-verified, no change to tracked fieldsv10
  4. Primary completion date: Jul 2021 to Jul 2023 Completion date: Dec 2021 to Dec 2024v9 Show 1 more changeShow less
    • Completion date: Dec 2021 to Dec 2024
  5. Re-verified, no change to tracked fieldsv8
Show 6 earlier versionsHide 6 earlier versions
  1. Study description expanded, about 19 wordsv7 See this version in full on ClinicalTrials.gov ↗
  2. Primary completion date: Jul 2019 to Jul 2021 Completion date: Dec 2019 to Dec 2021v6 Show 1 more changeShow less
    • Completion date: Dec 2019 to Dec 2021
  3. Secondary endpoints: 21 to 22v5 See this version in full on ClinicalTrials.gov ↗
  4. Primary completion date: Dec 2018 to Jul 2019 Completion date: Apr 2019 to Dec 2019v4 Show 1 more changeShow less
    • Completion date: Apr 2019 to Dec 2019
  5. Re-verified, no change to tracked fieldsv3
  6. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1 · Start date changed from estimate of Apr 2017 to Apr 11, 2017v2 Show 2 more changesShow less
    • Study sites: 0 to 1
    • Start date changed from estimate of Apr 2017 to Apr 11, 2017
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Protein-energy malnutrition (PEM) occurs in 65-90% of patients with liver cirrhosis. Severity of malnutrition correlates with progression of liver disease and leads to sarcopenia in 30-70% of cirrhotic patients. Malnutrition and sarcopenia are associated with an increased risk of complications and mortality. In cirrhosis the gut microbiome is altered leading to increased gut permeability, bacterial translocation and inflammation. Since the microbiome is involved in nutrient uptake and metabolism, it is hypothesized that microbiome alterations contribute to sarcopenia. A prospective controlled cohort study to investigate the interrelation of microbiome changes and sarcopenia in cirrhosis will be conducted. Furthermore the effect of nutritional interventions on the microbiome in cirrhosis will be studied. From this study information on how the gut microbiome composition and sarcopenia are associated in cirrhosis and if modulation of the gut microbiome by nutritional interventions is feasible will be collected.
Trial Details
NCT Number NCT03080129
Lead Sponsor Medical University of Graz
Conditions Sarcopenia, Liver Cirrhosis
Enrollment 120 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov